toxic to human beings and household pets, causing
painful death from kidney failure. In 1937 there was
no requirement for medications to be tested for tox-
icity before being placed on the market. The FD&C
Act of 1938 thus included a legal definition of a food
additive ‘‘any substance, the intended use of which
results directly or indirectly, in its becoming a com-
ponent or otherwise affecting the characteristics of
food’’
The FDA asks the following questions in evaluat-
ing a proposed new sweetener as a food additive:
How is the sweetener made?
What are its properties when it is added to foods or
beverages?
How much of the sweetener will be digested or oth-
erwise absorbed by the body?Are certain groups of people likely to be more sus-
ceptible than others to the additive?
Does the sweetener have any known toxic effects,
including hereditary disorders or cancer?
Other sweeteners are classified as generally
regarded as safeor GRAS, and are not defined for
legal purposes as food additives. The GRAS category
was created in 1958 when the FD&C Act was modified
by the passage of the Food Additives Amendment. A
sweetener, whether nutritive or nonnutritive, can be
given GRAS status on the basis of ‘‘experience based
on common use in food’’ or a scientific consensus
represented by published studies. Sorbitol and a few
other polyols have GRAS status along with the natu-
ral sugars. Most artificial sweeteners, however, are
considered food additives by the FDA.KEY TERMS
Acceptable daily intake level (ADI)—The level of a
substance that a person can consume every day over
a lifetime without risk. The ADIs for artificial sweet-
eners are very conservative measurements.
Carcinogen—A substance or other agent that causes
cancer. Some artificial sweeteners have been
banned in the United States on the grounds that
they may be carcinogens.
Food additive—Defined by the Federal Food, Drug,
and Cosmetic Act (FD&C) of 1938 as ‘‘any substance,
the intended use of which results directly or indi-
rectly, in its becoming a component or otherwise
affecting the characteristics of food.’’
Excipient—An inert substance, such as certain gums
or starches, used to make drugs easier to take by
allowing them to be formulated into tablets or
liquids. Some artificial sweeteners are used as
excipients.
Fructose—A simple sugar that occurs naturally in
sucrose and fruit. It can be added in combination
with sucrose in the form of high-fructose corn syrup
(HFCS) to sweeten foods because it is sweeter than
sucrose. Large amounts of fructose can cause diar-
rhea in infants and young children.
Generally recognized as safe (GRAS)—A phrase
used by the federal government to refer to exceptions
to the FD&C Act of 1938 as modified by the Food
Additives Amendment of 1958. Sweeteners that
have a scientific consensus on their safety, basedon either their use prior to 1958 or to well-known
scientific information, may be given GRAS status.
Gulf war syndrome (GWS)—A disorder character-
ized by a wide range of symptoms, including skin
rashes, migraine headaches, chronic fatigue, arthri-
tis, and muscle cramps, possibly related to military
service in the Persian Gulf war of 1991. GWS was
briefly attributed to the troops’ high consumption of
beverages containing aspartame, but this explana-
tion has been discredited.
High-intensity sweetener—Another term for nonnu-
tritive sweetener, used because these substances add
sweetness to food with very little volume.
Nonnutritive sweetener—Any sweetener that offers
little or no energy value when added to food.
Nutritive sweetener—Any sweetener that adds
some energy value to food.
Phenylketonuria (PKU)—A rare inherited metabolic
disorder resulting in accumulation of phenylalanine,
an amino acid, in the body. It can lead to mental
retardation and seizures. People with PKU should
not use products containing the artificial sweetener
aspartame because it is broken down into phenyl-
alanine (and other products) during digestion.
Sucrose—The natural sweetener commonly used as
table sugar; sucrose is a compound of two simple
sugars, glucose and fructose. It is used as the stand-
ard for measuring the sweetening power of high-
intensity artificial sweeteners.Artificial sweeteners